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Saphnelo recommended for approval in the EU by CHMP for the treatment of patients with systemic lupus erythematosus

20 December 2021

AstraZeneca’s Saphnelo (anifrolumab) has been recommended for marketing authorisation in the European Union (EU) as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite receiving standard therapy. SLE is a complex autoimmune condition that can affect any organ, and people often experience inadequate disease control, long-term organ damage and poor health-related quality of life. If approved, Saphnelo would be the first new treatment for SLE in Europe in more than a decade.

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